Kornimate/medical-research-clean huggingface dataset:
a study of cologuard™ in an average risk population assessing a three year test interval

Conditions: Colorectal Cancer Screening; Colorectal Cancer

Summary: this is a prospective longitudinal study to assess the impact of repeat cologuard testing at 3 years in average risk patients.

this is a prospective longitudinal study to assess the impact of repeat cologuard testing at 3 years in average risk patients. enrolled subjects will be prescribed cologuard per approved labeling at baseline. subjects with positive results will be referred to colonoscopy and study participation completed. subjects with negative cologuard results will be seen annually for 3 years. at year 3, subjects will repeat cologuard, followed by colonoscopy, regardless of the cologuard test outcome. subjects who have a colonoscopy at any time during the study will be discontinued following collection of the colonoscopy and associated histopathology results.

Eligibility criteria:
inclusion criteria: 1. subject has been prescribed cologuard for colorectal cancer screening 2. subject is at average risk for development of colorectal cancer 3. subject is 50 years or older 4. subject willing and able to sign informed consent. exclusion criteria: 1. subject had a colonoscopy in the previous 9 years 2. subject has undergone any double-contrast barium enema, virtual (ct-based) colonoscopy, or flexible sigmoidoscopy within the previous five (5) years. 3. subject has had a positive fecal occult blood test or fit within the previous six (6) months. 4. subject has any condition that in the opinion of the investigator should preclude participation in the study (e.g., subject not eligible for a diagnostic colonoscopy). 5. subject has a history of colorectal cancer or advanced adenoma. 6. subject has a history of aerodigestive tract cancer 7. subject has had a prior colorectal resection for any reason other than sigmoid diverticular disease 8. subject has had overt rectal bleeding, e.g. hematochezia or melena, within the previous 30 days. (blood on toilet paper, after wiping, does not constitute rectal bleeding) 9. subject has a diagnosis or personal history of any of the following high-risk conditions for colorectal cancer: * inflammatory bowel disease (ibd) including chronic ulcerative colitis (cuc) and crohn's disease. * 2 first-degree relatives who have been diagnosed with colon cancer. (note: first-degree relatives include parents, siblings and offspring). * one first-degree relative with crc diagnosed before the age of 60. 10. subject has a family history of: * familial adenomatous polyposis (also referred to as "fap", including attenuated fap). * hereditary non-polyposis colorectal cancer syndrome (also referred to as "hnpcc" or "lynch syndrome"). * other hereditary cancer syndromes including but are not limited to peutz-jeghers syndrome, myh-associated polyposis (map), gardner's syndrome, turcot's (or crail's) syndrome, cowden's syndrome, juvenile polyposis, cronkhite-canada syndrome, neurofibromatosis and familial hyperplastic polyposis.

Keywords: colorectal cancer colorectal cancer screening
evaluating the effect of oxygentherapy on concentration at chronic lung patients

Conditions: Lung Diseases, Interstitial; Pulmonary Disease, Chronic Obstructive

Summary: the objective is to study the cognitive functions in patients with chronic obstructive lung disease (cold) and patients with interstitial lung disease (ild) compared to healthy controls. the cognitive functions are tested with and without oxygen therapy to clarify the effect of oxygen therapy. driving simulations is used to test the cognitive functions. the hypothesis is that patients with chronic lung disease have decreased cognitive functions and that oxygen therapy will increase their cognitive functions.


Eligibility criteria:
inclusion criteria: * cold with forced expiratory volume at one second (fev1) \<50%, without long term oxygen therapy * cold with fev1 \<50%, with long term oxygen therapy * ild with diffusion capacity of lung for carbon monoxide (dlco) \< 50%, without long term oxygen therapy exclusion criteria: * comorbidity which decreases cognitive function * comorbidity which decreases concentration * physical comorbidity which makes it impossible to complete the test
video messages and vaccination intention

Conditions: COVID-19 Vaccination

Summary: this study uses an online panel survey to test the impact of video messages on stated likelihood of covid-19 vaccination. participants, who have self-identified as unvaccinated against covid-19, are randomly assigned to either no video message or 1 of 3 video messages to encourage vaccine take-up. the key endpoint is a question about the likelihood of getting vaccinated in the next 30 days.

this study uses an online panel survey to test the impact of video messages on stated likelihood of covid-19 vaccination. participants are recruited from the prolific.co platform. those who have indicated to prolific that they have not been vaccinated will be randomly assigned to either no video message or 1 of 3 video messages created by the vaccinate la/usc collaborative. the key endpoint is a question about the likelihood of getting vaccinated in the next 30 days.

Eligibility criteria:
inclusion criteria: * adults in the prolific.co panel * unvaccinated against covid-19 exclusion criteria: * indicated to prolific.co that they have received a covid-19 vaccination
effect of prevnar 13 on ear infections in children

Conditions: Otitis Media

Summary: prevnar (7 valent pneumococcal conjugate vaccine \[7vpnc\]) has been shown to be effective against ear infections in children. prevnar 13 is a new vaccine that is similar to prevnar. it is expected that the effectiveness of prevnar 13 against ear infections in children will be similar to that observed following prevnar. pfizer has committed to conduct a postmarketing study of the impact of prevnar 13 in reducing ear infections among children.

infants who have completed the prevnar 13 infant vaccination series who provide consent and fit the study inclusion criteria to participate in the study will be recruited.

Eligibility criteria:
inclusion criteria: * subject has received full (3-dose) infant series of prevnar 13 exclusion criteria: * prior vaccination with any 7vpnc. * prior vaccination with 23-valent pneumococcal polysaccharide vaccine (23vps). * any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in the study.

Keywords: acute otitis media prevnar 13 streptococcus pneumoniae nasopharyngeal colonization.
insulin sensitivity and metabolism before and after treatment in patients with hypothyroidism

Conditions: Hypothyroidism

Summary: the aim of this study is to further characterize the treatment related changes in insulin sensitivity, substrate metabolism and intra hepatic- and intramyocellular lipid content in patients with hypothyroidism


Eligibility criteria:
inclusion criteria: * written informed consent * must be of legal age and competent * age \> 18 years * presently diagnosed with hypothyroidism exclusion criteria: * alcohol consumption \>21 units per week * malignant disease * pregnancy * magnetic implants or material in the body * bmi \> 30 * heart disease (nyha \>2) * uncontrolled hypertension * manifest diabetes mellitus * changes in medication, with any influence on glucose metabolism, 2 months prior to and until the end of the trial.

Keywords: insulin sensitivity substrate metabolism fatty liver intramyocellular lipid intracellular signaling
registry of brentuximabvedotinin patients with r/r anaplastic large cell lymphoma or classical hl

Conditions: Relapsed or Refractory Anaplastic Large Cell Lymphoma & Hodgkin Lymphoma

Summary: in case of relapsed or refractory alk-negative alcl patients, high-dosage chemotherapy/ stem cell transplantation is a universal salvage option for patients with sensitivity to anti-cancer treatment and a relatively successful salvage rate can be expected. recently, there has been a report of successful stem cell transplantation with full response to brentuximabvedotin induced before stem cell transplantation and brentuximabvedotin's role as a bridge therapy before stem cell transplantation has also been suggested. hodgkin lymphoma is a type of curable blood cancer with unique tissues and clinical characteristics. based on the 2008 who classification, hodgkin lymphoma has two types-nodular lymphocyte predominant type and classical type-and the classical type is further classified into four types, nodular sclerosis, mixed cellularity, lymphocyte depletion and lymphocyte-rich type. recently, immune checkpoint inhibitor is reported as a very effective treatment for relapsed hodgkin lymphoma and more active treatment such as stem cell transplantation is considered for younger patients. treatment with brentuximabvedotin targeting cd30+ is also very effective for the treatment of relapsed hodgkin lymphoma and considered a good option for patients who are not suitable for stem cell transplantation or aged patients. it shows consistent response to anti-cd30 antibody treatment in relation to relapsed anaplastic large cell lymphoma or hodgkin lymphoma. the effect of brentuximabvedotin (bv) has been proven for relapsed or intractable alcl targeting cd30 as an antibody-chemical adhesive in the recent phase-2 study. as korea currently lacks real-world evidence in relation to bv, this study was conducted to address bv's effect as salvage therapy for patients with relapsed/refractoryanaplastic large cell lymphoma or hodgkin lymphoma. this study identified the clinical results for treatment patterns and patients using the collected data and derived critical evidence for treatment decisions.


Eligibility criteria:
inclusion criteria: any patient subject to one of the following at the start of treatment with brentuximabvedotin: 1. any patient planning to administer brentuximabvedotin to treat the target disease; 2. any patient administering brentuximabvedotin to treat the target disease; 3. any patient tracing brentuximabvedotin after treating the target disease; or 4. any patient administering another salvage option for cancer as the target disease has relapsed after terminating treatment using brentuximabvedotin. exclusion criteria: 1. if conditions for target diseases are not met. 2. if conditions for target patients are not met. 3. if patients do not give written consent to participate in study.
study of nasonex in the relief of nasal congestion in patients with seasonal allergic rhinitis (study p05583)

Conditions: Allergic Rhinitis

Summary: this study seeks to prospectively demonstrate that nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.


Eligibility criteria:
inclusion criteria: * a subject must be 12 years of age or older, of either sex, and of any race. * a subject must have at least a 2-year history of sar which exacerbates during the study season. * a subject must have a positive skin prick test response to an appropriate seasonal allergen at visit 1. * a subject must be clinically symptomatic at the screening and baseline visits. exclusion criteria: * a subject with a history of severe local reaction(s) or anaphylaxis to skin testing. * a subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the screening visit, or who has had a viral upper respiratory infection within 7 days prior to the screening visit. * a subject who has used any drug in an investigational protocol in the 30 days prior to the screening visit. * a subject who is participating in any other clinical study. * a subject who is part of the staff personnel directly involved with this study. * a subject who is a family member (parent, spouse, or sibling) of the investigational study staff. * a female subject who is breast-feeding, pregnant, or intends to become pregnant. * a subject previously randomized into this study. * a subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.
rhomboid intercostal block for video assisted thoracic surgery

Conditions: Lung Diseases

Summary: video assisted thoracic surgery (vats) has recently been evaluated as the standard surgical procedure for lung surgery. analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption. rhomboid intercostal block (rib) is a novel block and was first described by elsharkawy et al. it has been reported that rib may provide effective analgesia management for several surgeries like thoracotomy.

following video assisted thoracic surgery video assisted thoracic surgery (vats) has recently been evaluated as the standard surgical procedure for lung surgery. the advantages of vats prodecures compared with open thoracotomy are rapid recovery, short hospital stay and low complication risk. although vats is less painful than thoracotomy, patients may feel severe pain during the first hours at postoperative period. analgesia management is very important for these patients in postoperative period since insufficient analgesia can cause pulmonary complications such as atelectasis, pneumonia and increased oxygen consumption. rhomboid intercostal block (rib) is a novel block and was first described by elsharkawy et al. local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the t5-6 ribs 2-3 cm medially of the medial border of the scapula. rib targets both the posterior rami and lateral cutaneous branches of the thoracic nerves and provides analgesia for the hemithorax from t2 to t9. it has been reported that rib may provide effective analgesia management for several surgeries like thoracotomy. the aim of this study is to evaluate the efficacy us-guided rhomboid intercostal block compared to no intervention control group for postoperative analgesia management after vats. the primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (vas), adverse effects related with opioids (allergic reaction, nausea, vomiting) and complications due to block (pneumothorax, hematoma etc).

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) classification i-ii * scheduled for vats under general anesthesia exclusion criteria: * history of bleeding diathesis, * receiving anticoagulant treatment, * known local anesthetics and opioid allergy, * infection of the skin at the site of the needle puncture, * pregnancy or lactation, * patients who do not accept the procedure

Keywords: video assisted thoracic surgery postoperative pain management rhomboid intercostal block
ibi397 or combination therapies in patients with advanced malignancies

Conditions: Advanced Malignancies

Summary: the primary objective of this phase ia/ib study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of ibi397 or its combination therapies in patients with advanced malignancies


Eligibility criteria:
inclusion criteria: * have failed the standard treatment for locally advanced, recurrent or metastatic solid tumor or have failed at least the second line standard treatment (including autologous stem cell transplantation) or have failed the first line standard treatment and are not eligible for autologous stem cell transplantation * willing to and able to provide written informed consent for the trial and able to comply with protocol-specified visits and related procedures * ≥ 18 and ≤ 75 years of age on the day of signing the informed consent * have a performance scale of 0 or 1 on the eastern cooperative oncology group performance status (ecog ps) * subjects with solid tumor: have at least one measurable or assessable lesion as defined by recist v1.1; subjects with lymphoma: have at least one measurable or assessable lesion as defined by lugano2014 criteria exclusion criteria: * has been previously exposed to any cd47 antibody, sirpα antibody, or cd47/sirpα recombinant protein or other inhibitors that target the same pathway * is currently participating in another interventional study, except for observational (non-interventional) study or in the survival follow-up phase of an interventional study * requires long-term systemic hormone or any other immunosuppressive drug therapy, excluding inhaled hormone therapy * has acute or chronic active hepatitis b (defined as hepatitis b surface antigen \[hbsag\] and/or hepatitis b core antibody positive \[hbcab\] and hepatitis b virus \[hbv\] dna copy number ≥ 1 × 104 copies/ml or ≥ 2000 iu/ml or higher than the lower limit of detection) or acute or chronic active hepatitis c virus (hcv) antibody positive; hcv antibody positive but rna negative subjects are allowed * has a known history of severe allergic reaction to other monoclonal antibodies, or is allergic to any component of the ibi397 formulation. * is pregnant or breastfeeding
bone marrow aspirate compared to platelet rich plasma for treating knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: this study is intended to compare whether bone marrow aspirate concentrate or platelet rich plasma injections is more effective in treating knee osteoarthritis.

while prp shows promise in helping restore function to these patients, there are still concerns with prp's long term outcomes. another option that has become more popular for physicians treating this debilitation condition is bone marrow aspirate concentrate (bma), which use's undifferentiated cells found in the bone marrow to promote healing and tissue regeneration. these cells have the ability to replicate into a multiple different tissue types. with bma, the marrow is concentrated provide better healing of the damaged tissue and aid in growth and repair. the full benefits of bma are still unknown, but studies have shown the treatment can reduce swelling, relieve pain, and improve healing in articular cartilage and bone grafts. autologous bma has shown promising clinical potential as a therapeutic agent in regenerative medicine, including the treatment of osteoarthritis and cartilage defects, and the clinical efficacy platelet rich plasma has been documented to alleviate symptoms related to knee osteoarthritis. however, randomized, prospective comparison of the two techniques has not been reported in the literature and long term follow-up for both treatments is limited, and especially limited in the use of bma for osteoarthritis treatment.

Eligibility criteria:
inclusion criteria: * male or female age 18-80 years * knee osteoarthritis * subjects must present with pain or swelling to target knee for at least 4 months * kellgren-lawrence score between 1 and 3 upon x-ray evaluation * must be willing and able to provide informed consent * willing and able to return for scheduled follow-up visits exclusion criteria: * major mechanical axis deviation of more than 50% into either compartment (varus or valgus ) * have had a corticosteroid injection within 3 months or a hyaluronic acid injection within 6 months * history of the following medical conditions: * diabetes * autoimmune disorders * disorders requiring immunosuppression * rheumatoid arthritis * hemophilic arthropathy * infectious arthritis * charcot's knee * paget's disease of the femur or tibia * cancer * ongoing infectious disease * significant cardiovascular, renal or hepatic disease

Keywords: knee osteoarthritis platelet rich plasma (prp) bone marrow concentrate (bmc)
evaluation of the effectiveness of the volara system determined by sputum movement and production

Conditions: Bronchiectasis Adult; COPD

Summary: the aim of this study is to evaluate the therapeutic effect of therapy with the volara system on mucus clearance.

the aim of this study is to evaluate the therapeutic effect of therapy with the volara system on mucus clearance. mucus volume (ml) measured by functional respiratory imaging (fri). fri is a quantitative endpoint that identifies mucus plugs in the segmented airways. mucus volume will be assessed based on movement of mucus plugs and/or clearance from segmental airways. ct scans are obtained to determine fri and will be obtained and assessed at baseline and after the 4-week treatment period to assess changes in mucus volume within the airways, associated with the volara treatment. the study will also provide insight into the mechanism of action of the therapy.

Eligibility criteria:
inclusion criteria: 1. documented diagnosis of copd with or without bronchiectasis. 2. age ≥ 21 years. 3. naive to volara therapy. 4. fev1 \< 80% predicted (based on pulmonary function tests within the past 12 months). 5. daily sputum production over the prior 2 weeks. 6. signed informed consent. 7. stable pulmonary disease defined as no change in disease status. 8. stable medication regimen for 30 days prior to visit 1, defined as no change in prescribed medications and adherence to their prescribed medications for pulmonary disease exclusion criteria: 1. anticipated requirement for hospitalisation within the next 35 days (± 1 day). 2. history of pneumothorax within the past 6 months prior to visit 1. 3. history of haemoptysis requiring embolization within the past 12 months prior to visit 1. 4. inability or unwillingness to perform volara system therapy as directed, without healthcare provider support. 5. inability or unwillingness to complete study visits and/or provide follow-up data as required per the study protocol. 6. inability to complete a 6-minute walk. 7. actively participating in another clinical trial involving an investigational medication or device. 8. pregnant females as verified by point of care human chorionic gonadotropin test. 9. current intrapulmonary percussive ventilation and/or oscillation and lung expansion users. 10. participant requires a prescribed daily regimen for airway clearance with a device or with manual therapy in addition to volara. 11. participant requires mechanical ventilation. 12. participants with artificial airways

Keywords: volara ole therapy mucous clearance